Device recall
Z-1570-2025: HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU…
FDA device recall · Class I · Thoratec LLC
Key facts
| Recall number (Z-number) | Z-1570-2025 |
|---|---|
| Recall event | 96471 |
| Product | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System. |
| Product code | DSQ |
| Recalling firm | Thoratec LLC |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P060040, P160054 |
| FEI number | 2916596 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database